Today, regulatory reviewers want to verify results and assess the robustness and validity of submitted data. Biostats groups, therefore, need an easy way to automate end-to-end traceability between plans for analysis, the tabulation data and its values, the analysis data, and the analyses performed to streamline the submission readiness process, all while more efficiently meeting regulatory requirements.

End­-to-­end Traceability and Control
The Phase Forward Statistical Control Environment (SCE) offers complete system control and end­-to-­end traceability within one environment to fully optimize your statistical analysis workflows. In addition to full user access control with complete versioning and auditing capabilities, all of the data, Statistical Analysis Plan (SAP) specifications, programs, macros and the outputs are automatically tracked by the system to provide detailed dependency relationship links that can be viewed graphically. These dependency relationships can also be generated in reports and directly deposited into a document management system, helping biostatistical groups easily manage, check and document their work.

Reduce the Time it Takes to Collect, Re­run or Replicate Analyses
The Phase Forward SCE supports “as-of” processing that allows retrospective analysis of data even after the CDR has been updated. The system can create a snapshot of the CDR at a given point in time, allowing analysis and results based on earlier data to be reproduced. Data that was available at the time the conclusion was drawn and submitted to regulatory authorities can then be included. The “as-of” processing gives organizations the ability to quickly and easily respond to regulatory requests during the critical period of regulatory review.

The Most Up-to-date Information
Real-time status updates about existing data and information contained within the environment are provided by the Phase Forward SCE. The system lets users know if study components such as tables, listings and figures are “up-to-date” or “stale.” The ability of the system to track and manage the dependencies between related elements in a study and take snapshots over time allows users to always have access to up-to-date as well as historical information. Decision makers are given the power to act on the latest information.

Streamline the Submission Readiness Process
The Phase Forward SCE can manage metadata for effective and efficient submissions. Any organization submitting a New Drug Application has to produce analysis and supporting data for its regulatory submissions. For a single New Drug Application this could represent thousands of analysis results and their associated datasets. Typically, this is the last step in the analysis and submissions process and is currently performed manually. This represents a significant manpower and time investment near the critical deadline period of submission. Incomplete or inaccurate documentation accompanying such a submission can result in delays as regulatory authorities ask for clarifications and supplemental submissions.

Using automation and software to ensure timely and accurate documentation for accompanying submissions streamlines this process. The system can create Define.pdf and Define.xml. The Phase Forward SCE also supports the direct publication of objects such as PDF reports to Documentum®, LiveLink® or other electronic document management systems.